Under-Represented Communities Diagnosed With SCD or MCI Through Tele-Cog

NCT ID: NCT06542458

Last Updated: 2025-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-01

Study Completion Date

2032-01-01

Brief Summary

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Overall, this study's primary aim is to establish a prospective, longitudinal, observational cohort study of older adults at risk for dementia from under-resourced/underrepresented communities. More specifically, older adults diagnosed with subjective cognitive decline (SCD) or Mild Cognitive Impairment (MCI) during clinical care offered via the Tele-Cog clinic would be recruited for more comprehensive data collection to characterize the clinical presentation and course of illness over multiple timepoints spread out longitudinally.

Detailed Description

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Clinical data obtained as part of standard of care will be collected from the medical record (including clinical diagnosis, cognitive and other neuropsychological test scores, lab results, neuroimaging data, etc.) and additional data (neuropsychological test batteries and clinical questionnaires if not already obtained) would be obtained at research study visits.

Participants will be asked to participate in annual research visits for up to 5 years.

Conditions

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Mild Cognitive Impairment Subjective Cognitive Decline

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Study Population

Adults ages 50 years and older who are fluent in English and are diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up

Assessments

Intervention Type BEHAVIORAL

Participants will undergo a standard battery of neuropsychological measures, behavioral questionnaire, and functional assessment to monitor cognition and function over time. Clinical data obtained as part of standard of care will be collected from the medical record

Neuroimaging volumetric measures

Intervention Type OTHER

Neuroimaging volumetric measures will be obtained from already conducted standard of care neuroimaging.

Biofluid samples

Intervention Type OTHER

Biofluid sampling data will be obtained through another protocol. All participants will be required to sign that consent to participate in this trial.

Interventions

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Assessments

Participants will undergo a standard battery of neuropsychological measures, behavioral questionnaire, and functional assessment to monitor cognition and function over time. Clinical data obtained as part of standard of care will be collected from the medical record

Intervention Type BEHAVIORAL

Neuroimaging volumetric measures

Neuroimaging volumetric measures will be obtained from already conducted standard of care neuroimaging.

Intervention Type OTHER

Biofluid samples

Biofluid sampling data will be obtained through another protocol. All participants will be required to sign that consent to participate in this trial.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Adults ages 50 years and older
2. Diagnosed with subjective cognitive concerns (SCD) or objective cognitive decline with mostly intact functioning (MCI diagnosis) as part of clinical work up
3. Fluent in English
4. Able to provide voluntary informed consent
5. Willing and able to undergo all study procedures
6. Able to delegate, if possible, a study partner to contribute information regarding daily activities and cognition

Exclusion Criteria

1. Diagnosis of dementia at baseline.
2. Inability to give informed consent.
3. High risk of adverse emotional or behavioral reaction based on investigator's clinical evaluation (e.g., evidence of serious personality disorder, antisocial behavior, serious current stressors, lack of meaningful social support).
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University

OTHER

Sponsor Role lead

Responsible Party

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Douglas Scharre

Professor-Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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The Ohio State University

Columbus, Ohio, United States

Site Status

Countries

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United States

Central Contacts

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Jessica Pommy, PhD

Role: CONTACT

614-293-4969

Other Identifiers

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NEW-64541

Identifier Type: -

Identifier Source: org_study_id

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